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CDRH New Pilot on High-Risk Recalls

[ Price : $8.95]

CDRH says a new device recall pilot program aims to improve communication timeliness about corrective actions being taken by compa...

IC-Green Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Renew Pharmaceuticals IC-Green (indocyanine green) was not withdrawn from sale for re...

MXBBB Recalls Umary Hyaluronic Acid Tablets

[ Price : $8.95]

FDA says MXBBB has recalled one lot of Umary hyaluronic acid caplets that contain undisclosed diclofenac and omeprazole.

Over 290 OCI Arrests in FY 2023: FDA

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FDA assistant commissioner Justin Green reports on over 290 arrests last year by the agencys Office of Criminal Investigations.

Burdensome Device Assessment Guidance: Post

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Two medical device experts use a Hyman, Phelps & McNamara post to urge FDA to provide additional guidance to ease what they see as...

Johns Hopkins Surgeon Eyed for FDA Top Job

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News outlets report that Johns Hopkins surgeon Marty Makary is likely to be nominated by president-elect Donald Trump as the next ...

Need for Device Transparency Seen in Celect Case

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Academic medical center authors writing in the Annals of Internal Medicine say litigation involving the Cook Celect IVC filter dem...

PCCP Draft Guidance Stakeholder Recommendations

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Two stakeholders request changes to an FDA draft guidance on predetermined change control plans for medical devices.

Draeger Atlan Recall is Class 1

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FDA says the Draeger recall correction of its Atlan A350 and A350XL anesthesia workstations is Class 1.

Smiths Recalls Infusion Pump Battery Packs

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Smiths Medical recalls (Class 1) its CADD-Solis Li-ion Rechargeable Battery Packs to update instructions for use due to a potentia...